Specialist Manufacturing – Investigations

Amgen; Holly Springs (NC); Vor Ort; USD 108.000 - 146.000; Vollzeit

Benefits dieser Stelle

Retirement plan

Bonus program

Stock-based incentives

Zusammenfassung

Amgen is seeking a highly experienced investigator to lead major deviation investigations at the North Carolina biologics manufacturing site. You will interface with GMP manufacturing, process development, facilities, automation, EHSS, and Quality to ensure compliant investigations and effective CAPAs.

The role requires strong project management, cross-functional collaboration, and clear technical writing. Flexible work models and competitive benefits are included.

Qualifikationen

• Experience with compliance, problem-solving, and root cause analysis tools (5-whys, fishbone, Kepner Tregoe).
• Ability to manage major deviation investigations and develop CAPAs.
• Strong documentation and technical writing skills.
• Experience presenting to inspectors during regulatory inspections and internal audits.

Aufgaben

• Manage major deviation investigations, assemble teams, lead root cause analyses, and document findings.
• Drive improvements to the investigation process and present findings to stakeholders.
• Coordinate cross-functional teams through complex investigations and meet milestones.

Kenntnisse

Root cause analysis

Problem solving

Cross-functional collaboration

Regulatory communications

Ausbildung

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

Tools

Veeva QMS

Jobbeschreibung

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including, Process Development, Facilities & Engineering, Automation, EHSS, and Quality.

This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

What you will do

• Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Drive improvements to the investigation process.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress to impacted areas and leadership.
• Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
• Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
• Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem-solving approach.
• Apply inductive and deductive reasoning in the investigation process.
• Clear and concise technical writing.
• Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
• Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.

What we expect of you

The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications

• Doctorate degree
• Master’s degree & 3 years of directly related experience
• Bachelor’s degree or & 5 years of directly related experience
• Associate’s degree & 10 years of directly related experience
• High school diploma / GED & 12 years of directly related experience

Preferred Qualifications

• 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis®, Design of Experiment etc.) critical thinking, project management, and quality systems.
• Degree in Science or Engineering
• Experience leading complex investigations
• Experience using Veeva QMS for Deviation investigations and CAPAs
• Demonstrated project management ability
• Experience presenting to inspectors during regulatory inspections and internal audits.
• Excellent written and verbal communication skills
• Ability to work in a team matrix environment and build relationships with partners
• Strong interpersonal skills

What you can expect of us

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Objects in your future are closer than they appear.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range 107,545.40USD -145,502.60 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen